U.S. patent application number 13/126329 was filed with the patent office on 2011-10-27 for cuvette and method for authenticating a cuvette.
This patent application is currently assigned to KONINKLIJKE PHILIPS ELECTRONICS N.V.. Invention is credited to Markus Laubscher, Milan Petkovic, Boris Skoric, Pim Tuyls.
Application Number | 20110259091 13/126329 |
Document ID | / |
Family ID | 41531537 |
Filed Date | 2011-10-27 |
United States Patent
Application |
20110259091 |
Kind Code |
A1 |
Laubscher; Markus ; et
al. |
October 27, 2011 |
CUVETTE AND METHOD FOR AUTHENTICATING A CUVETTE
Abstract
A cuvette (10) for storing a biological sample to be analyzed by
means of a predefined detection technique is disclosed. The cuvette
(10) is formed from a moldable material that contains particles
(15a, 15b) at a concentration within a predefined range. The
particles (15a, 15b) are randomly distributed, in order to form a
unique pattern. Moreover, the particles (15a, 15b) have measurable
physical properties, so that the unique pattern is detectable using
the detection technique that is used to analyze the biological
sample. The unique properties obtained by the randomly distributed
particles (15a, 15b) render copying nearly impossible, since it is
more complicated to distribute the particles in a predetermined
pattern than to let them distribute randomly.
Inventors: |
Laubscher; Markus;
(Eindhoven, NL) ; Tuyls; Pim; (Mol, BE) ;
Petkovic; Milan; (Eindhoven, NL) ; Skoric; Boris;
(S-hertogenbosch, NL) |
Assignee: |
KONINKLIJKE PHILIPS ELECTRONICS
N.V.
EINDHOVEN
NL
|
Family ID: |
41531537 |
Appl. No.: |
13/126329 |
Filed: |
November 2, 2009 |
PCT Filed: |
November 2, 2009 |
PCT NO: |
PCT/IB2009/054859 |
371 Date: |
July 15, 2011 |
Current U.S.
Class: |
73/64.56 ;
235/375; 264/319; 422/554 |
Current CPC
Class: |
B01L 3/545 20130101;
G01N 2035/00742 20130101; G01N 21/03 20130101; B01L 2300/168
20130101; G06K 9/00577 20130101; G01N 2021/0321 20130101; B01L
2300/021 20130101 |
Class at
Publication: |
73/64.56 ;
422/554; 264/319; 235/375 |
International
Class: |
B01L 3/00 20060101
B01L003/00; G06F 17/00 20060101 G06F017/00; G01N 1/00 20060101
G01N001/00; B29C 43/02 20060101 B29C043/02 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 6, 2008 |
EP |
08168446.6 |
Claims
1. A cuvette (10) for storing a biological sample to be analyzed by
means of a predefined detection technique, said cuvette (10) being
formed from a moldable material containing particles (15a-b) at a
concentration within a predefined range, said particles (15a-b)
being randomly distributed, in order to form a unique pattern (14),
said particles (15a-b) having measurable physical properties, so
that said unique pattern (14) is detectable using said detection
technique.
2. The cuvette (10) according to claim 1, having a handle portion
(11) and an introducible portion (12) adapted to be introduced into
a measuring device (12), at least a portion of said introducible
portion (12) being a sample holding portion (13) for storing of a
biological sample, wherein said unique pattern (14) is comprised in
said introducible portion (12) outside said sample holding portion
(13).
3. The cuvette (10) according to claim 1, wherein the size of said
particles (15a-b) are in the order of micrometers, preferably
ranging from 1 to 10 micrometers.
4. The cuvette (10) according to claim 1, further provided with a
readable label (16), wherein said label (16) contains a stored
digital representation of said unique pattern (14).
5. The cuvette (10) according to claim 1, wherein said label (16)
is readable using said detection technique, and arranged adjacent
to said unique pattern (14).
6. The cuvette (10) according to claim 1, wherein the physical
properties are at least one of reflectivity and transmittivity.
7. The cuvette (10) according to claim 6, wherein said detection
technique is optical detection of an image.
8. A method for manufacturing a cuvette (10) for storing a
biological sample to be analyzed by means of a predefined detection
technique, comprising the steps of: providing a moldable material
containing particles (15a-b) at a concentration within a predefined
range, which particles (15a-b) have measurable physical properties;
and forming a cuvette (10) from said material, so that said
particles (15a-b) are randomly distributed, in order to form a
unique pattern (14), which is detectable using said detection
technique.
9. The method for manufacturing a cuvette (10) further comprising
the step of providing said cuvette (10) with a readable label (16)
containing a stored digital representation of said unique pattern
(14).
10. The method of claim 9, wherein said label (16) is provided
adjacent to said unique pattern (14), and is readable using said
detection technique.
11. A method for authenticating a cuvette (10) formed from a
moldable material comprising particles (15a-b) having measurable
physical properties, said particles (15a-b) being randomly
distributed, in order to form a unique detectable pattern, which
method comprises the steps of: introducing (302) the cuvette (10)
into a measuring device (20) that is intended to analyze a
biological sample, such as a blood sample; and detecting (403) the
unique pattern (14) using said measuring device (20).
12. The method according to claim 11, wherein the cuvette (10) is
provided with a label (16), said label (16) comprising a stored
digital representation of the unique pattern (14) the method
further comprising the steps of reading (401) said stored digital
representation from the label (16); and comparing (404) the stored
digital representation with the detected unique pattern (14).
13. A method for analyzing a biological sample, such as a blood
sample, comprising the steps of: storing (301) a biological sample
on a cuvette (10) formed from a moldable material comprising
particles (15a-b) having measurable physical properties, said
particles (15a-b) being randomly distributed, in order to form a
unique detectable pattern; authenticating (303) the cuvette (10) by
means of the method of claim 11 or 12; and analyzing (304) said
biological sample with said measuring device.
14. A system for analyzing a biological sample comprising: a
measuring device (20) adapted to analyze (304) a biological sample
stored on a cuvette (10); and detect (403) a unique pattern (14)
formed from particles (15a-b) having measurable physical properties
being randomly distributed in said cuvette; and an authentication
device (30) adapted to receive information from the measuring
device (20); and authenticate (303) said cuvette (10) based on said
information
15. The authentication system in claim 14, further comprising: a
reader (40) adapted to read a label (16) provided on said cuvette
(10) and storing a digital representation of the unique pattern
(14); said authentication device (30) further being adapted to
receive information from the reader (40).
Description
TECHNICAL FIELD
[0001] The present invention relates to a cuvette for storing a
biological sample to be analyzed by a measuring device. The
invention also relates to a method for authentication of a
cuvette.
BACKGROUND OF THE INVENTION
[0002] In health care today an increasing amount of analysis of
biological samples are performed instantly at the point of care due
to for example developed techniques in this area. The increasing
use of biological analysis causes usage of an increased amount of
disposable cuvettes on which a biological sample, such as a blood
sample, is stored. When performing the analysis the cuvette is
introduced to a measuring device that generates an analysis
result.
[0003] Low cost producers have noticed that the profit is made
through selling such disposable cuvettes, rather than selling the
actual measuring device to which a cuvette is introduced, whereby
copying of cuvettes by low cost producers has become a problem.
Cuvettes being produced by low cost producers impacts on the
quality of cuvettes that leads to decreased reliability of analysis
results when the copied cuvettes are used in measuring devices
intended for the original cuvettes.
[0004] In an attempt to give a unique identity to a known cuvette
it could be labeled with an identifier, such as a bar code.
However, labeling requires additional steps in the manufacturing
process and such a label is moreover relatively easy to reproduce.
Therefore, there is a need for a cuvette that cannot be easily
reproduced to thereby obtain reliable test results and that can be
easily authenticated to its corresponding measuring device.
SUMMARY OF THE INVENTION
[0005] In view of the above mentioned need, a general object of the
present invention is to provide a cuvette that cannot be easily
reproduced, and which is adapted to be authenticated. This and
other objects are achieved through a cuvette for storing a
biological sample to be analyzed by means of a predefined detection
technique, the cuvette being formed from a moldable material, such
as a plastic material, containing particles at a concentration
within a predefined range. The particles are randomly distributed,
in order to form a unique pattern, and the particles have
measurable physical properties, so that the unique pattern is
detectable using the detection technique.
[0006] The unique pattern of the present invention is used as an
identifier of the cuvette, and is integrated in the material from
which the cuvette is formed, by means of randomly distributed
particles. The unique properties obtained by the randomly
distributed particles render copying nearly impossible, since it is
more complicated to distribute the particles in a predetermined
pattern than to let them distribute randomly.
[0007] Furthermore, the physical properties of the particles being
measurable renders the unique pattern detectable, and by that means
each cuvette holds a unique detectable identity. In addition, the
pattern being detectable using the same detection technique as for
detecting the biological sample forms a basis for a simple
authentication of the cuvette using the same technique as when
analyzing the biological sample. In other words, the cuvette of the
present invention is less laborious to give the unique properties
to, more complicated to copy than cuvettes of prior art, and
adapted to easily be authenticated without requiring additional
equipment.
[0008] The cuvette may moreover have a handle portion and an
introducible portion adapted to be introduced into a measuring
device, at least a portion of the introducible portion being a
sample holding portion for storing of a biological sample, wherein
the unique pattern is comprised in the introducible portion outside
the sample holding portion with the result that the unique pattern
may be introduced to a measuring device together with the
biological sample. The unique pattern being separated from the
sample holding portion forms a basis for a correct analysis result
as well as a correctly executed authentication of the cuvette.
[0009] Further, the size of the particles may be in the order of
micrometers, preferably ranging from 1 to 10 micrometers, such as
micro beads, having the properties to be easily detected by
detection techniques used for sample analysis. Furthermore, the
particles may have such properties so that they easily distribute
in the moldable material, which hence simplifies the manufacturing
process, and the achievement of the unique pattern. An example of
particle material is glass.
[0010] The cuvette may be provided with a readable label, wherein
the label contains a stored digital representation of the unique
pattern, which forms a basis for a reliable authentication of the
cuvette, where the stored digital representation may be compared to
the unique pattern of the cuvette.
[0011] The label may be readable using the same detection
technique. In this case, the label is preferably arranged adjacent
to the unique pattern, so that only one image is enough to both
read the label and detect the unique pattern.
[0012] Further, the physical properties may be at least one of
reflectivity and transmittivity, in which case the detection
technique may be optical detection of an image. This is a suitable
technique for obtaining a representation of the unique pattern and
to read the stored representation of the label, which technique is
also a common technique for analyzing a biological sample. Other
detection techniques include for example chemical analysis.
[0013] According to a second aspect of the present invention there
is provided a method for manufacturing a cuvette for storing a
biological sample to be analyzed by means of a predefined detection
technique. The method comprises the steps of providing a moldable
material containing particles at a concentration within a
predefined range, which particles have measurable physical
properties; and forming a cuvette from the material, so that the
particles are randomly distributed, in order to form a unique
pattern, which is detectable using the detection technique.
[0014] Providing the particles constituting the unique properties
already in the manufacturing process is a relatively simple way to
achieve unique properties, since it belongs to the nature of such
particles, such as micro beams, to distribute randomly in the
moldable material. Moreover, as described in relation to the
cuvette according to the present invention copying such a cuvette
is nearly impossible, since it is much more complicated to
manufacture a cuvette by inserting particles in a predetermined
pattern, than to let them distribute randomly.
[0015] According to a third aspect of the present invention, there
is provided a method for authenticating a cuvette formed from a
moldable material comprising particles having measurable physical
properties, the particles being randomly distributed, in order to
form a unique, detectable pattern. The method comprises the steps
of introducing the cuvette into a measuring device that is intended
to analyze a biological sample, such as a blood sample; and
detecting the unique pattern of the cuvette using the measuring
device.
[0016] Re-using a measuring device that is intended for performing
an analysis of a biological sample for also detecting the unique
pattern of the cuvette is efficient and practical. No additional
detection device is hence required for this purpose, and the effect
of with certainty preventing usage of copied products in a
measuring device is obtained.
[0017] When the cuvette is provided with a label comprising a
stored digital representation of the unique pattern the method may
further comprise the steps of reading the stored digital
representation from the label to be verified; and comparing the
stored digital representation with the detected unique pattern to
thereby achieve a reliable result of authentication.
[0018] Moreover, the label may be readable using equipment used to
detect the unique pattern, so as to be readable by the measuring
device. In this case, the label is preferably provided adjacent to
the unique pattern, so that only one image is enough to both read
the label and detect the unique pattern.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] In the following, embodiments of the present invention will
be described in detail, with reference to the accompanying,
exemplifying drawings on which:
[0020] FIG. 1 is a perspective view of a cuvette and a measuring
device according to the present invention.
[0021] FIG. 2 is a perspective view of a system for analyzing a
biological sample and for authenticating a cuvette.
[0022] FIG. 3 is a flow chart schematically illustrating an
exemplary method for analyzing a biological sample of the present
invention.
[0023] FIG. 4 is a flow chart schematically illustrating an
exemplary method for authenticating a cuvette performed by the
measuring device.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0024] The present invention will be mainly described hereinafter
with reference to a cuvette 10 illustrated in FIG. 1.
[0025] The cuvette 10 is formed from a moldable material, e.g. a
plastic material, that comprises particles 15a-b, such as glass
micro beads, that are randomly distributed in the moldable material
before the cuvette 10 is molded. The properties of the particles
15a-b are moreover measurable.
[0026] The cuvette 10 comprises a handle portion 11 and an
introducible portion 12. The handle portion 11 of the cuvette 10 is
adapted to be held by a user when storing a blood sample from a
patient, and for simplifying insertion of the introducible portion
12 of the cuvette 10 into a measuring device. The introducible
portion 12 of the cuvette 10 is further divided into a sample
holding portion 13, where the blood sample is stored, and an
authentication portion 14, adapted to uniquely identify the cuvette
10, by the properties achieved by particles 15a-b. The particles
15a-b form a unique pattern due to the unique location and
orientation in relation to each other of these particles 15a-b for
each cuvette 10. Since the properties of the particles 15a-b are
measurable the unique pattern may be both detected and stored, for
example by means of taking an image of the pattern. The unique
pattern of the authentication portion 14 of the cuvette 10 is as
mentioned dedicated for the purpose of identifying the cuvette.
[0027] There is a label 16 provided on the cuvette, that contains a
stored digital representation of the unique pattern of the cuvette,
and alternatively also a digital signature. In more detail the
label may for example have been produced by first taking an image
of the authentication portion 14 of the unique pattern, which image
has been transformed into a compact digital representation. The
signature has then been generated from the digital representation
for example by means of using a signing algorithm. Signing may be
performed by using for example a private key of a certification
authority. The digital representation and the digital signature has
thereafter been combined into so called enrolment data, which is
printed or otherwise provided as a label 16 on the cuvette 10, in
the form of for example a bar code, a block code, or an electronic
identifier, such as an RFID. Alternatively, the digital
representation is stored e.g. in a database in the device that
performs the authentication method.
[0028] By digitally signing the digital representation it is more
difficult for a malicious party to generate valid data, since it
also requires a valid signature.
[0029] In FIG. 2 a system for analyzing a blood sample that is
stored on the cuvette and for authenticating the cuvette is
illustrated. The system comprises a measuring device 20 intended to
perform blood sample analysis, an authentication device 30
connected to the measuring device 20, and a reader 40 connected to
the authentication device 30.
[0030] The measuring device 20 has a display 21 for displaying
analysis data etc, and an opening 22 in which the cuvette 10 may be
inserted. The measuring device 20 is intended for analyzing a blood
sample, which is achieved through image detection techniques. As an
alternative to optical detection of an image, the detection may be
based on for example electrical or chemical techniques. In
operation the cuvette 10 is inserted to the measuring device 20,
whereby the unique pattern of the authentication portion 14 may be
detected and the blood sample which is stored on the sample holding
portion 13 of the cuvette 10 may be analyzed using the same
detection technique, performed by the measuring device 20.
[0031] The reader 40 is adapted to read the label of the cuvette
10, and depending on the type of label 16, the reader 40 may be for
example a bar code reader or a block code reader.
[0032] The authentication device 30 is arranged to receive data
which is read by the reader 40 and to authenticate the cuvette 10
using this information, which is further described in relation to
FIGS. 3 and 4. The authentication device 30 may be a micro
processor.
[0033] Alternatively the reader 40 and the authentication device 30
are part of the measuring device.
[0034] An example of a method for analyzing a biological sample,
here a blood sample, will now be described with reference to FIG. 3
which is a flow chart schematically illustrating such a method.
[0035] First, in step 301, a blood sample is taken from a patient
at a point of care, and is stored at the sample holding portion of
the cuvette 10. Thereafter, in step 302, the cuvette 10 is inserted
to the opening 22 of the measuring device 20.
[0036] In step 303 the cuvette is authenticated by means of an
authentication method that will be further described with reference
to FIG. 4. If the authentication is successful, meaning that the
cuvette 10 is an original cuvette that is to be used in the
measuring device 20 in question, step 204 is performed.
[0037] In step 304 the blood sample is analyzed according to
conventional methods performed by the measuring device 20.
[0038] An example of a method for authenticating a cuvette will now
be described with reference to FIG. 4 which is a flow chart
schematically illustrating such a method. The method may be
implemented in the authentication device 30 by storing computer
program code portions in the device 30, a processor controlling the
method described hereinafter
[0039] First, in step 401, the reader 40 reads the label 16
provided on the cuvette 10.
[0040] The digital signature and the digital representation are
transmitted to the authentication device 30. Thereafter, in step
402, the authentication device 30 verifies the digital signature
comprised in the label 16. The verification is performed by using
the public key corresponding to the private key used when producing
the digital signature. Only if this verification is valid, the next
step 403 is performed, otherwise the program control proceeds to
step 405, waiting for next cuvette to be verified.
[0041] In step 403, after a valid verification of the digital
signature and the cuvette has been inserted into the measuring
device 20, the unique pattern is detected for example by means of
taking an image of the pattern from a designated authentication
portion 14 outside the sample holding portion of the cuvette 10. A
representation of the detected unique pattern is transmitted to the
authentication device.
[0042] Next, in step 404, the digital representation that was read
from the label 16 in step 301 is compared to the detected unique
pattern, by the authentication device 30. If the consistency
between these two is not sufficient the cuvette 10 is considered to
be fake, and is not compatible with the measuring device 20 in
question.
[0043] In case there is no digital signature the steps concerning
the digital signature may accordingly be left out of the
method.
[0044] Step 401 and 403 of reading the label 16 and detecting the
unique pattern may moreover be executed at the same time, by the
measuring device 20, if the properties of the cuvette 10 allow that
the same technique is used for both reading the label and detecting
the unique pattern, for example by taking an image using a
microscope. This may be achieved by using a photoactive dye inside
the cuvette 10 which can be modified with a laser. Moreover, it
requires that the label 16 and the unique pattern 14 be arranged
adjacent to each other.
[0045] The person skilled in the art realizes that the present
invention is not limited to the preferred embodiments. For example
the particle properties may be of any measurable kind, such as
intensity, or color, the unique pattern may be measured by various
detection techniques and combinations of these, such as only
reflective measurements, or both reflective and transmission
measurements, etc.
[0046] Such and other obvious modifications must be considered to
be within the scope of the present invention, as it is defined by
the appended claims. It should be noted that the above-mentioned
embodiments illustrate rather than limit the invention, and that
those skilled in the art will be able to design many alternative
embodiments without departing from the scope of the appended
claims. In the claims, any reference signs placed between
parentheses shall not be construed as limiting to the claim. The
word "comprising" does not exclude the presence of other elements
or steps than those listed in the claim. The word "a" or "an"
preceding an element does not exclude the presence of a plurality
of such elements. Further, a single unit may perform the functions
of several means recited in the claims.
* * * * *